Inclusion Criteria:

¨

- Histological confirmed prostate cancer

- Macroscopic metastatic disease

- Prior treatment with Docetaxel

- Castration resistant disease defined as:Serum testosterone (< 0.5 ng/ml) and:

- Increase in measurable disease (RECIST 1.1, see appendix 10) or

- For non-measurable disease, the appearance of at least one new lesion on nuclear
scintigraphy) or

- A rising PSA from the previous reference value on 2 consecutive occasions at least
one week apart

- Written informed consent

Exclusion Criteria:

- Less than 21 days since prior treatment with chemotherapy

- Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less
than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone
or other new agents.

- Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic
radiotherapy is not an exclusion criteria)

- Persistent adverse events from previous cancer therapies > grade 1 (CTCAE - Version
4.0) with the exception of alopecia. (With respect to peripheral neuropathy and nail
changes grade 2 is acceptable)

- ECOG performance status > 1

- Known CNS malignancy

- Within 6 months of randomization:

- myocardial infarction,

- unstable angina,

- angioplasty,

- bypass surgery,

- stroke,

- TIA, or

- congestive heart failure NYHA class III or IV

- Within 3 months prior to randomization:

- treatment resistant peptic ulcer disease,

- infectious or inflammatory bowel disease,

- pulmonary embolism

- Any severe acute or chronic medical condition that places the patient at
increased risk of serious toxicity or interferes with the interpretation of
study results

- History of hypersensitivity to docetaxel or polysorbate 80

- Inadequate organ and bone marrow function as evidenced by:

- Hemoglobin < 9.0 g/dL

- Absolute neutrophil count < 1.5 x 109/L,

- Platelet count < 100 x 109/L,

- AST/SGOT and/or ALT/SGPT > 1.5 x ULN;

- Total bilirubin > 1.0 x ULN,

- Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine
clearance will be calculated according to CKD-EPI formula and patients with
creatinine clearance < 60 mL/min should be excluded (http://mdrd.com/ for
on-line calculation)

- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450
3A4/5. A one week wash out period is necessary for patients who are already on these
treatments.

- Patients with reproductive potential not implementing accepted and effective method
of contraception.